Ertapenem

Ertapenem

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 658684423

Effective Date

November 27, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Ertapenem(1 g in 20 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

44647-051

Application Number

ANDA207647

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

November 27, 2023

Ingredients

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

SODIUM BICARBONATEInactive

Code: 8MDF5V39QOClass: IACT

Code: 2T90KE67L0Class: ACTIMQuantity: 1 g in 20 mL